Reported Aug 27, 2014 · Terminated

Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b)…

Wockhardt USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Wockhardt Usa Inc. · 20 Waterview Blvd., Suite 3 · Parsippany, NJ · 07054

Is this the product you have?

  • Wockhardt Metoprolol Succinate Extended-Release Tablets, USP 200 mg, a) 100-count bottle (NDC 64679-737-02), b) 500-count bottle (NDC 64679-737-03) Rx only
  • Manufactured byWockhardt Limited Mumbai
  • India Distributed byWockhardt USA LLC 20 Waterview Boulevard. Parsippany, NJ 07054 USA
Lot codes and dates
    • Lot # a) LN11005
    • Exp 04/15
    • LN11006
    • Exp 04/15
    • b) LN10979
    • Exp. 04/15
    • LN10980
    • Exp. 04/15
Amount recalled
11,661 HDPE bottles

Where it was sold

  • Nationwide

Why it was recalled

Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 20, 2015 · Data as of Sep 19, 5:02 PM UTC

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